About this trial
The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
6-12 yrs
Verbal IQ > 70 (to ensure verbal skills are sufficient to participate in treatment)
participation of child's parent or legal guardian living in the same home
child diagnosed with insomnia, 5) willing to accept random assignment.
Disqualifiers
child unable to provide informed consent or child unable to provide assent
child unwilling to accept random assignment
child participation in another randomized research project
child unable to complete forms or implement treatment procedures due to cognitive impairment
Trial design
Crossover
Treatments tested in this trial
CBT-I
BehavioralCognitive behavioral therapy for insomnia
Treatment groups
Trial outcomes
Primary outcomes
Electronic Sleep Diaries - Child
Primary: child sleep onset latency (lights-out until sleep onset) and total sleep time. All other sleep diary variables are secondary (e.g., sleep efficiency (total sleep time/time in bed x 100%). Child (with caregiver assistance) and caregiver complete electronic diaries each morning (\~5 mins) during each 1-week assessment and throughout treatment.
Actigraphy - Child
Primary variables: child sleep onset latency and total sleep time. All other actigraphy variables are secondary. Children wear actigraphs (Fitbit Inspire 3, Google), watch-like device, that monitors light and gross motor activity. Data analyzed using 30s epochs. Validated algorithm estimates SOL, TST, WASO, sleep efficiency and other variables provided by diaries. A combination of diary and actigraphy data estimates bed/waketime variability. Children wear devices 24/7 during each 1-week assessment.
Session Completion
Percentage of treatment sessions completed
Treatment Adherence
Percentage of instructions followed as indicated on treatment adherence logs
Secondary outcomes
Child Sleep Habits Questionnaire-Abbreviated
The Child Sleep Habits Questionnaire - Abbreviated consists of 22 questions regarding child sleep behaviors on a 1 point scale (0 = never, 7 = always). Higher scores indicating issues with sleep habits.
Pediatric Symptom Checklist-17
The Pediatric Symptom Checklist-17 is a 17-item questionnaire that measures attention, internalizing, and externalizing problems on a 0-2 scale. Scores range from 0-34 with higher score indicates a greater level of psychosocial impairment.
Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2)
The Behavior Rating Inventory of Executive Function -2nd Edition (BRIEF-2) is an 86-item caregiver-report measure of day-to-day executive functioning and impairment. T-scores ranging from 30-90 with higher scores indicating greater executive functioning difficulties
Pediatric Daytime Sleepiness Scale
The Pediatric Daytime Sleepiness Scale is an 8-item questionnaire that measures daytime sleepiness and school-related outcomes on a 5-point scale. Scores range from 0-32 with higher scores indicating greater daytime sleepiness.
Other outcomes
Pubertal Development Scale (PDS)
Self-report questionnaire used to assess pubertal status
Sponsors and contacts
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